FDAClass IIJuly 3, 2024

CDC, Influenza A/H5 Subtyping Kit recall

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

Why was CDC, Influenza A/H5 Subtyping Kit recalled?

The H5b component may fail to amplify, resulting in an inconclusive result.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: Catalog # FluIVD03-11, lot 220307

Product
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Recalling firm
Centers For Disease Control and Prevention
Quantity
191 units
Distribution
US Nationwide distribution.
Recall date
July 3, 2024
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls